Early viral kinetics and treatment outcome in combination of high-dose interferon induction vs. pegylated interferon plus ribavirin for naive patients infected with hepatitis C virus of genotype 1b and high viral load

[Guest guest]

J Med Virol. 2005 Jan;75(1):27-34.

Early viral kinetics and treatment outcome in combination of high-dose

interferon induction vs. pegylated interferon plus ribavirin for naive

patients infected with hepatitis C virus of genotype 1b and high viral load.

Tsubota A, Arase Y, Someya T, Suzuki Y, Suzuki F, Saitoh S, Ikeda K, Akuta

N, Hosaka T, Kobayashi M, Kumada H.

Department of Gastroenterology, Toranomon Hospital, Minato-ku, Tokyo, Japan.

An investigation was carried out to determine whether early viral monitoring

could predict efficiently the virological response to combination therapy of

two different regimens in treatment-naive chronic hepatitis C patients

infected with genotype 1b with high baseline viral load. Patients were

randomly assigned to receive interferon (IFN) alpha-2b induction (6 MU daily

for 2 weeks) followed by 6 MU thrice weekly for 46 weeks (IFN/R group; n =

20), or pegylated IFN alpha-2b (1.5 mug/kg) weekly for 48 weeks (PEG/R

group; n = 28), in combination with ribavirin (600-1,000 mg daily). Serum

HCV RNA was quantitated at 0, 6, 12, 24, and 48 hr post-dose, weekly during

the first 4 weeks, and thereafter viral kinetics were assessed every 4

weeks. The sustained virological response rates in the IFN/R and PEG/R

groups were 40% (8/20) and 43% (12/28), respectively. The non-virological

response rates were 40% (8/20) and 39% (11/28), respectively. The cumulative

virological response rates were similar in both groups. Multivariate

analyses identified no independent baseline variables linked to sustained

virological or non-virological response. Early log viral load changes from

baseline in both groups were significantly greater at all time-points after

24 hr in virological response patients than in non-virological response

patients (P < 0.001 for all). On the receiver operating characteristics

curves for prediction of non-virological response, the area under the curves

(0.951-1.000), sensitivity (90%-100%), and negative predictive value (96%-

100%) were similar at any time-points after 24 hr. For prediction of

sustained virological response, sensitivity of 80% with 86% negative

predictive value was observed for negative HCV RNA at week 12, with the

highest area under the curves value of 0.919. The results suggest that early

monitoring of viral kinetics is a useful measure to predict virological

response, and might facilitate development of rational and effective

therapeutic strategies. J. Med. Virol. 75:27-34, 2005. © 2005 Wiley-Liss,

Inc.

PMID: 15543591 [PubMed - in process]

[Guest guest]

J Med Virol. 2005 Jan;75(1):27-34.

Early viral kinetics and treatment outcome in combination of high-dose

interferon induction vs. pegylated interferon plus ribavirin for naive

patients infected with hepatitis C virus of genotype 1b and high viral load.

Tsubota A, Arase Y, Someya T, Suzuki Y, Suzuki F, Saitoh S, Ikeda K, Akuta

N, Hosaka T, Kobayashi M, Kumada H.

Department of Gastroenterology, Toranomon Hospital, Minato-ku, Tokyo, Japan.

An investigation was carried out to determine whether early viral monitoring

could predict efficiently the virological response to combination therapy of

two different regimens in treatment-naive chronic hepatitis C patients

infected with genotype 1b with high baseline viral load. Patients were

randomly assigned to receive interferon (IFN) alpha-2b induction (6 MU daily

for 2 weeks) followed by 6 MU thrice weekly for 46 weeks (IFN/R group; n =

20), or pegylated IFN alpha-2b (1.5 mug/kg) weekly for 48 weeks (PEG/R

group; n = 28), in combination with ribavirin (600-1,000 mg daily). Serum

HCV RNA was quantitated at 0, 6, 12, 24, and 48 hr post-dose, weekly during

the first 4 weeks, and thereafter viral kinetics were assessed every 4

weeks. The sustained virological response rates in the IFN/R and PEG/R

groups were 40% (8/20) and 43% (12/28), respectively. The non-virological

response rates were 40% (8/20) and 39% (11/28), respectively. The cumulative

virological response rates were similar in both groups. Multivariate

analyses identified no independent baseline variables linked to sustained

virological or non-virological response. Early log viral load changes from

baseline in both groups were significantly greater at all time-points after

24 hr in virological response patients than in non-virological response

patients (P < 0.001 for all). On the receiver operating characteristics

curves for prediction of non-virological response, the area under the curves

(0.951-1.000), sensitivity (90%-100%), and negative predictive value (96%-

100%) were similar at any time-points after 24 hr. For prediction of

sustained virological response, sensitivity of 80% with 86% negative

predictive value was observed for negative HCV RNA at week 12, with the

highest area under the curves value of 0.919. The results suggest that early

monitoring of viral kinetics is a useful measure to predict virological

response, and might facilitate development of rational and effective

therapeutic strategies. J. Med. Virol. 75:27-34, 2005. © 2005 Wiley-Liss,

Inc.

PMID: 15543591 [PubMed - in process]

[Guest guest]

J Med Virol. 2005 Jan;75(1):27-34.

Early viral kinetics and treatment outcome in combination of high-dose

interferon induction vs. pegylated interferon plus ribavirin for naive

patients infected with hepatitis C virus of genotype 1b and high viral load.

Tsubota A, Arase Y, Someya T, Suzuki Y, Suzuki F, Saitoh S, Ikeda K, Akuta

N, Hosaka T, Kobayashi M, Kumada H.

Department of Gastroenterology, Toranomon Hospital, Minato-ku, Tokyo, Japan.

An investigation was carried out to determine whether early viral monitoring

could predict efficiently the virological response to combination therapy of

two different regimens in treatment-naive chronic hepatitis C patients

infected with genotype 1b with high baseline viral load. Patients were

randomly assigned to receive interferon (IFN) alpha-2b induction (6 MU daily

for 2 weeks) followed by 6 MU thrice weekly for 46 weeks (IFN/R group; n =

20), or pegylated IFN alpha-2b (1.5 mug/kg) weekly for 48 weeks (PEG/R

group; n = 28), in combination with ribavirin (600-1,000 mg daily). Serum

HCV RNA was quantitated at 0, 6, 12, 24, and 48 hr post-dose, weekly during

the first 4 weeks, and thereafter viral kinetics were assessed every 4

weeks. The sustained virological response rates in the IFN/R and PEG/R

groups were 40% (8/20) and 43% (12/28), respectively. The non-virological

response rates were 40% (8/20) and 39% (11/28), respectively. The cumulative

virological response rates were similar in both groups. Multivariate

analyses identified no independent baseline variables linked to sustained

virological or non-virological response. Early log viral load changes from

baseline in both groups were significantly greater at all time-points after

24 hr in virological response patients than in non-virological response

patients (P < 0.001 for all). On the receiver operating characteristics

curves for prediction of non-virological response, the area under the curves

(0.951-1.000), sensitivity (90%-100%), and negative predictive value (96%-

100%) were similar at any time-points after 24 hr. For prediction of

sustained virological response, sensitivity of 80% with 86% negative

predictive value was observed for negative HCV RNA at week 12, with the

highest area under the curves value of 0.919. The results suggest that early

monitoring of viral kinetics is a useful measure to predict virological

response, and might facilitate development of rational and effective

therapeutic strategies. J. Med. Virol. 75:27-34, 2005. © 2005 Wiley-Liss,

Inc.

PMID: 15543591 [PubMed - in process]

[Guest guest]

J Med Virol. 2005 Jan;75(1):27-34.

Early viral kinetics and treatment outcome in combination of high-dose

interferon induction vs. pegylated interferon plus ribavirin for naive

patients infected with hepatitis C virus of genotype 1b and high viral load.

Tsubota A, Arase Y, Someya T, Suzuki Y, Suzuki F, Saitoh S, Ikeda K, Akuta

N, Hosaka T, Kobayashi M, Kumada H.

Department of Gastroenterology, Toranomon Hospital, Minato-ku, Tokyo, Japan.

An investigation was carried out to determine whether early viral monitoring

could predict efficiently the virological response to combination therapy of

two different regimens in treatment-naive chronic hepatitis C patients

infected with genotype 1b with high baseline viral load. Patients were

randomly assigned to receive interferon (IFN) alpha-2b induction (6 MU daily

for 2 weeks) followed by 6 MU thrice weekly for 46 weeks (IFN/R group; n =

20), or pegylated IFN alpha-2b (1.5 mug/kg) weekly for 48 weeks (PEG/R

group; n = 28), in combination with ribavirin (600-1,000 mg daily). Serum

HCV RNA was quantitated at 0, 6, 12, 24, and 48 hr post-dose, weekly during

the first 4 weeks, and thereafter viral kinetics were assessed every 4

weeks. The sustained virological response rates in the IFN/R and PEG/R

groups were 40% (8/20) and 43% (12/28), respectively. The non-virological

response rates were 40% (8/20) and 39% (11/28), respectively. The cumulative

virological response rates were similar in both groups. Multivariate

analyses identified no independent baseline variables linked to sustained

virological or non-virological response. Early log viral load changes from

baseline in both groups were significantly greater at all time-points after

24 hr in virological response patients than in non-virological response

patients (P < 0.001 for all). On the receiver operating characteristics

curves for prediction of non-virological response, the area under the curves

(0.951-1.000), sensitivity (90%-100%), and negative predictive value (96%-

100%) were similar at any time-points after 24 hr. For prediction of

sustained virological response, sensitivity of 80% with 86% negative

predictive value was observed for negative HCV RNA at week 12, with the

highest area under the curves value of 0.919. The results suggest that early

monitoring of viral kinetics is a useful measure to predict virological

response, and might facilitate development of rational and effective

therapeutic strategies. J. Med. Virol. 75:27-34, 2005. © 2005 Wiley-Liss,

Inc.

PMID: 15543591 [PubMed - in process]